Status:
COMPLETED
Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
California HIV/AIDS Research Program
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects. Subjects will be inel...
Detailed Description
The purpose of this study is to determine how well a new anti-HIV drug combination (RAL plus LPV/r) taken twice a day decreases the amount of HIV found in participants' blood (viral load) compared to ...
Eligibility Criteria
Inclusion
- Documented HIV-1 infection.
- Treatment naïve (defined as having never received any HIV antiretroviral agents in past).
- CD4+ T-cell count greater than or equal to 50 cells/mm3
- HIV viral load greater than or equal to 5,000 copies/mL
- Laboratory values obtained by screening laboratories within 30 days of entry:
- Absolute neutrophil count (ANC) greater than 750/mm3.
- Hemoglobin greater than 8.0 g/dL.
- Platelet count greater than 50,000/mm3.
- Calculated creatinine clearance (CrCl) \> 60 mL/min as estimated by the Cockcroft-Gault equation:
- For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)
- For women, multiply the result by 0.85 = CrCl (mL/min)
- AST (SGOT), ALT (SGPT), and alkaline phosphatase less than 5 x ULN.
- Total bilirubin less than 2.5 x ULN.
- Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
- Men and women age greater than or equal to 18 years.
- Ability to obtain prescription for HIV antiretroviral medications and to have required prescriptions filled prior to entry.
- Ability and willingness of subject to give written informed consent
Exclusion
- Pregnancy or breast-feeding
- Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry (day 0).
- Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to study entry (day 0).
- Evidence of HIV seroconversion within 6 months prior to study entry.
- Evidence of any major HIV drug resistance-associated mutation on any genotype performed prior to study entry or at the time of screening.
- History of chronic hepatitis C (defined as HCV antibody positive and HCV RNA detectable).
- History of chronic active hepatitis B (defined as surface antigen positive and/or HBV DNA detectable).
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
- Use of human growth hormone within 30 days prior to study entry.
- Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed).
Key Trial Info
Start Date :
August 26 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2014
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00752856
Start Date
August 26 2008
End Date
February 11 2014
Last Update
July 22 2020
Active Locations (6)
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1
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
2
University Southern California
Los Angeles, California, United States, 90033
3
Univerisity California Irvine
Orange, California, United States, 92868
4
Desert AIDS Project
Palm Springs, California, United States, 92262